Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
42 participants
OBSERVATIONAL
2022-12-16
2025-06-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Sleep Deprivation on Malnutrition in ICU (Intensive Care Unit) Patients
NCT07032441
Treatment Intensity/Factors Predicting Short and Long Term Outcomes in Elderly Critically Ill Patients
NCT00554684
MONITOR-IC: Determining and Improving Long-term Consequences of ICU Care
NCT03246334
One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated
NCT01679171
Impact of Frailty and ICU-AW on Post-ICU Fatigue Self-reported
NCT05984069
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients with prolonged stays (≥14 days) account for between 4 and 11% of admissions to intensive care. By definition, intensive care is a place where patients may experience psychological distress and physical pain. Anxiety and depression, sleep disorders, disruption of the circadian rhythm and sleep debt frequently occur during a stay in intensive care and can hinder the patient's recovery. Measures that are simple in theory, aimed at promoting well-being, are sometimes very difficult to implement in such an acute care setting. Consequently, patients whose stay in intensive care is prolonged, whose clinical condition is stable but who still require 'intensive' care, particularly in relation to mechanical ventilation, muscle weakness and limited autonomy, will require control of these sources of psychological and physical suffering in the hope of promoting their well-being and even improving their rehabilitation. In intensive care, the main sources of discomfort are related to the environment (noise and excessive light) or work organisation, but also to more or less invasive care procedures: procedures associated with ventilation (tracheal suction, extubation), repeated blood sampling, catheter insertion, patient positioning in bed (pain associated with immobilisation, change of position, etc.). Numerous studies report very high noise levels in intensive care units, well above the recommended levels of 45 dB, due to alarms, equipment (ventilators, nebulisers, etc.), the behaviour of paramedical staff, and also medical staff (peaks during visits). An interesting alternative may then be to transfer the patient to a specific unit, either for weaning and rehabilitation or for continuous post-resuscitation care.
In Rouen, for example, there is a respiratory weaning and rehabilitation unit with specialised nursing staff in an environment considered more conducive to weaning and rehabilitation (specific paramedical team, daytime activities, no night-time admissions, corridor lights turned off at night, reasoned monitoring of vital signs). This unit could also be conducive to better control of environmental disturbances to ensure normal circadian rhythms and sufficient quantity and quality of sleep.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Assessment of sleep quality
Sleep quality will be assessed each night in intensive care using a Richards-Campbell sleep questionnaire and an intensive care sleep questionnaire, completed by the patient.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* clinically stable (no amines or sedation for more than 48 hours)
* hospitalised for more than 7 days in intensive care
* conscious
* with no central neurological pathology
* with no major cognitive impairment
* with no sleep disorder (OSA, insomnia, restless legs syndrome)
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Rouen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Rouen Hospital
Rouen, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-A02632-37
Identifier Type: OTHER
Identifier Source: secondary_id
2020/294/OB
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.